Si-Hyuck Kang

Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis

BACKGROUND The aim of this study was to compare the safety and efficacy of biodegradable-polymer (BP) drug-eluting stents (DES), bare metal stents (BMS), and durable-polymer DES in patients undergoing coronary revascularization, we performed a systematic review and network meta-analysis using a Bayesian framework. METHODS AND RESULTS Study stents included BMS, paclitaxel-eluting (PES), sirolimus-eluting (SES), endeavor zotarolimus-eluting (ZES-E), cobalt-chromium everolimus-eluting (CoCr-EES), platinium-chromium everolimus-eluting (PtCr-EES), resolute zotarolimus-eluting (ZES-R), and BP biolimus-eluting stents (BP-BES). After a systematic electronic search, 113 trials with 90 584 patients were selected. The principal endpoint was definite or probable stent thrombosis (ST) defined according to the Academic Research Consortium within 1 year. RESULTS Biodegradable polymer-biolimus-eluting stents [OR, 0.56; 95% credible interval (CrI), 0.33-0.90], SES (OR, 0.53; 95% CrI, 0.38-0.73), CoCr-EES (OR, 0.34; 95% CrI, 0.23-0.52), and PtCr-EES (OR, 0.31; 95% CrI, 0.10-0.90) were all superior to BMS in terms of definite or probable ST within 1 year. Cobalt-chromium everolimus-eluting stents demonstrated the lowest risk of ST of all stents at all times after stent implantation. Biodegradable polymer-biolimus-eluting stents was associated with a higher risk of definite or probable ST than CoCr-EES (OR, 1.72; 95% CrI, 1.04-2.98). All DES reduced the need for repeat revascularization, and all but PES reduced the risk of myocardial infarction compared with BMS. CONCLUSIONS All DESs but PES and ZES-E were superior to BMS in terms of ST within 1 year. Cobalt-chromium everolimus-eluting stents was safer than any DES even including BP-BES. Our results suggest that not only the biodegradability of polymer, but the optimal combination of stent alloy, design, strut thickness, polymer, and drug all combined determine the safety of DES.

Safety and efficacy of everolimus-versus sirolimus-eluting stents: a systematic review and meta-analysis of 11 randomized trials

BACKGROUND While EES have proven superior to paclitaxel-eluting stents, it remains uncertain whether EES improve clinical outcomes compared to SES, which are the most efficacious among the first-generation drug-eluting stents. We performed a meta-analysis of randomized trials comparing the efficacy and safety of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary intervention. METHODS From online and offline search until December 2011, we identified 11 randomized trials (total 12,869 patients). The primary endpoint was major adverse cardiac events. RESULTS The risk of major adverse cardiac events did not differ significantly between the patients treated with EES versus SES [OR, 0.90 (95% CI, 0.77-1.04); P = .162]. However, we found a significant reduction in the risk of repeat revascularization in the EES arm [OR, 0.85 (95% CI, 0.71-1.00); P = .047]. There were no significant differences regarding the risk of cardiac death [OR, 0.97 (95% CI, 0.74-1.27); P = .834], or myocardial infarction [OR, 0.95 (95% CI, 0.75-1.20), P = .656]. The risk of definite or probable stent thrombosis tended to be lower [OR, 0.68 (95% CI, 0.45-1.02); P = .065], while definite ST was significantly lower [OR, 0.44 (95% CI, 0.25-0.80); P = .007] with EES. CONCLUSIONS In a large systematic overview of comparative trials involving percutaneous revascularization with drug-eluting stents, treatment with EES significantly reduced the risk of repeat revascularization and definite ST compared to SES. We found no significant differences in the risk of cardiac death or myocardial infarction.

Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

OBJECTIVES This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. BACKGROUND To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). METHODS Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. RESULTS A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. CONCLUSIONS Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices.

Early- and late-term clinical outcome and their predictors in patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction

BACKGROUNDS The disparity between ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) remains controversial. We compared clinical outcomes and prognostic factors between STEMI and NSTEMI using large-scale registry data. METHODS We recruited 28,421 patients with STEMI (n=16,607) and NSTEMI (n=11,814) between November 2005 and April 2010 from a nationwide registry in Korea. We performed landmark analysis of cardiac death, recurrent acute myocardial infarction (re-AMI), revascularization, and major adverse cardiac events (MACE) at 30 days (early term) and 1 year (late term) after admission. RESULTS Patients with NSTEMI had a greater number of co-morbidities than STEMI patients. Early term MACE (6.9% vs. 4.5%, p<0.001) and cardiac death (6.1% vs. 3.7%, p<0.001) were higher in STEMI patients. However, late-term MACE (8.0% vs. 9.1%, p=0.007), cardiac death (1.9% vs. 2.6%, p=0.001), and re-AMI (0.6% vs. 1.3%, p<0.001) were lower in the STEMI group. The independent predictors of cardiac death were old age, renal dysfunction, LV dysfunction, Killip class, post-thrombolysis in myocardial infarction (TIMI) flow, and major bleeding in both groups. Female gender, previous ischemic heart disease, diabetes, current smoking, multivessel disease, and body mass index were MI type- or time-dependent predictors. CONCLUSION The STEMI group displayed poor early term clinical outcome, whereas the NSTEMI group displayed poor late-term clinical outcome. The STEMI and NSTEMI groups had different predictor profiles for cardiac death, suggesting that different strategies are required for improving the late-term outcome of STEMI and NSTEMI patients.

Sex Differences in Management and Mortality of Patients With ST-Elevation Myocardial Infarction (from the Korean Acute Myocardial Infarction National Registry)

There has been controversy over the disparity between men and women with regard to the management and prognosis of acute myocardial infarction. Analyzing nationwide multicenter prospective registries in Korea, the aim of this study was to determine whether female gender independently imposes a risk for mortality. Data from 14,253 patients who were hospitalized for ST-segment elevation myocardial infarction from November 2005 to September 2010 were extracted from registries. Compared to men, women were older (mean age 56 ± 12 vs 67 ± 10 years, p < 0.001), and female gender was associated with a higher frequency of co-morbidities, including hypertension, diabetes, and dyslipidemia. Women had longer pain-to-door time and more severe hemodynamic status than men. All-cause mortality rates were 13.6% in women and 7.0% in men at 1 year after the index admission (hazard ratio for women 2.01, 95% confidence interval 1.80 to 2.25, p < 0.001). The risk for death after ST-segment elevation myocardial infarction corresponded highly with age. Although the risk remained high after adjusting for age, further analyses adjusting for medical history, clinical performance, and hemodynamic status diminished the gender effect (hazard ratio 1.00, 95% confidence interval 0.86 to 1.17, p = 0.821). Propensity score matching, as a sensitivity analysis, corroborated the results. In conclusion, this study shows that women have a comparable risk for death after ST-segment elevation myocardial infarction as men. The gender effect was accounted for mostly by the womens older age, complex co-morbidities, and severe hemodynamic conditions at presentation.

Underweight is a risk factor for atrial fibrillation: A nationwide population-based study

BACKGROUND Obesity is a well-known risk factor for development of atrial fibrillation (AF). However, the impact of underweight on AF has not been previously recognized. We sought to determine the risk of AF in subjects with underweight in this study. METHODS We analyzed clinical data from a total of 132,063 individuals with the age of 40years or older who received health care checkups arranged by the national insurance program between 2003 and 2004. Newly diagnosed nonvalvular AF was identified using claim data during a median follow-up duration of 9.0years. RESULTS The mean body mass index (BMI) of patients was 23.9kg/m(2), and 3,323 individuals (2.5%) were classified as being underweight (BMI <18.5kg/m(2)). During the study period, 3,237 individuals (2.5%) developed AF. There was a U-shaped relationship between BMI and AF occurrence: Each 1.0kg/m(2) increase of BMI above 20kg/m(2) was associated with a 6% increased risk of AF (p<0.001), while each 1.0kg/m(2) lower BMI below 20kg/m(2) was associated with a 13% increased risk of AF (p<0.001) after multivariable adjustment. Underweight was significantly associated with 23% increased risk of AF, while obesity classes I and II were with 26% and 120% increased risk of AF, respectively. Excess risk of AF in the underweight was independent of thyroid disease, chronic lung disease, or history of malignancy, and was not attributable to cigarette smoking, low socioeconomic status, excessive physical activity, or heavy alcohol consumption. CONCLUSION BMI has a U-shaped relationship with the risk of AF. Underweight was an independent risk factor for AF independent of confounding factors such as chronic lung disease and malignancy. These findings suggest that underweight is associated with biological effects that contribute to the development of AF.

Impact of intravascular ultrasound guidance in routine percutaneous coronary intervention for conventional lesions: data from the EXCELLENT trial

BACKGROUND Intravascular ultrasound (IVUS) offers tomographic images of coronary artery, helping physicians refine percutaneous coronary intervention (PCI) procedures. However, it is still controversial whether routine use of IVUS in conventional lesions leads to improvement in clinical outcomes after PCI. METHODS From the EXCELLENT trial, patients were grouped into IVUS-guided versus IVUS-non-guided PCI (619 and 802 patients, respectively). The crude patients as well as the propensity score matched pairs were compared with regard to clinical outcomes. RESULTS Baseline characteristics showed younger age and lower incidence of comorbidities in the IVUS group. IVUS-guided PCI was associated with more aggressive treatment such as longer stenting length, larger stent diameter, and greater number of stents implanted. In the total population, IVUS guidance was associated with a significantly higher risk of periprocedural MI with no significant differences in other outcomes. In the matched cohort (463 matched pairs, 926 patients), IVUS guidance was associated with significantly increased risk of target lesion failure (4.3% vs. 2.4%; p=0.047 by conditional logistic regression) and major adverse cardiovascular events at 1 year almost exclusively due to increased risk of periprocedural myocardial infarction (MI) (1.6% vs. 0.2%; p=0.050), while the rates of cardiac death, spontaneous MI, and target lesion revascularization did not differ significantly between the two groups. CONCLUSIONS The adjunctive use of IVUS during PCI was associated with more stents implanted, longer stenting, and bigger stenting. There were no significant advantages of IVUS guidance, but rather a significant increase in periprocedural enzyme elevation, reflecting more aggressive procedures performed with IVUS guidance.

Prognostic value of NT-proBNP in heart failure with preserved versus reduced EF

Objective Plasma level of N-terminal–pro-brain natriuretic peptide (NT-proBNP) is a reliable prognostic factor in patients with heart failure (HF). However, it is unclear how differently the biomarker predicts adverse outcomes in HF with preserved EF (HFpEF) versus HF with reduced EF (HFrEF). Methods From the Korean Heart Failure registry, a prospective multicentre cohort for consecutive patients who were hospitalised for acute HF syndrome, those with available NT-proBNP and LVEF measurements were extracted. Patients with LVEF ≥50% were categorised as the HFpEF group (N=528) and those with ≤40% as the HFrEF group (N=1142). Results Patients with HFpEF had significantly lower NT-proBNP level than those with HFrEF (median 2723 vs 5644 ng/L, p<0.001). Event-free survival did not differ between the two groups either in terms of death from any cause (88.4% vs 86.9%; p=0.471) or the composite of death or HF readmission at 1 year (73.8% vs 70.6%; p=0.225). High levels of NT-proBNP were significantly associated with poor outcomes. However, the relationship was not different among the HFpEF and HFrEF groups (interaction p=0.956 for all-cause death; p=0.351 for the composite of all-cause death or HF hospitalisation). Conclusions Plasma level of NT-proBNP is the most powerful prognostic factor in both HFpEF and HFrEF. Although patients with HFpEF have lower NT-proBNP levels, the prognosis of a patient with HFpEF expected from a given NT-proBNP level is similar with his/her counterpart with HFrEF.

Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation: the HOST-ASSURE randomized trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Safety & Effectiveness of Drug-Eluting Stents & Anti-platelet Regimen).

OBJECTIVES This study sought to test the noninferiority of triple antiplatelet therapy (TAT) versus double-dose clopidogrel dual antiplatelet therapy (DDAT) in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND Antiplatelet regimen is an integral component of medical therapy after PCI. A 1-week duration of doubling the dose of clopidogrel was shown to improve outcome at 1 month compared with the conventional dose in patients with acute coronary syndrome undergoing PCI. Yet in Asia, the addition of cilostazol is used more commonly than DDAT in high-risk patients. METHODS We randomly assigned 3,755 all-comers undergoing PCI to either TAT or DDAT, which was continued for 1 month, to test the noninferiority of TAT versus DDAT. The primary outcome was the cumulative incidence of net clinical outcome at 1 month post-PCI defined as the composite of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO (Platelet Inhibition and Patient Outcomes) major bleeding. RESULTS TAT was noninferior to DDAT with respect to the primary outcome, which occurred in 1.2% and 1.4% of patients, respectively (-0.22% absolute difference, 0.34% 1-sided 97.5% confidence interval, p = 0.0007 for noninferiority; hazard ratio: 0.85; 95% confidence interval: 0.49 to 1.48; p = 0.558 for superiority). The individual risks of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO major bleeding did not differ significantly between the 2 groups. There were no significant between-group differences in the treatment effect with regard to the rate of the primary outcome. CONCLUSIONS The adjunctive use of cilostazol was noninferior to doubling the dose of clopidogrel for 1 month in all-comers undergoing PCI with exclusively drug-eluting stents. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).

Coronary Artery Bypass Grafting Versus Drug-Eluting Stent Implantation for Left Main Coronary Artery Disease (from a Two-Center Registry)

Recent studies have suggested that percutaneous coronary intervention (PCI) in patients with unprotected left main coronary artery (LMCA) disease renders outcomes comparable to those from coronary artery bypass grafting (CABG). It is necessary to stratify individual patient risk and select the optimal revascularization strategy. We compared the clinical outcomes of patients with unprotected LMCA disease who had undergone PCI with drug-eluting stents or CABG. We identified 462 patients who were treated from January 2003 to December 2006 for unprotected LMCA or LMCA-equivalent disease: 257 had undergone CABG and 205 had undergone PCI with drug-eluting stents. Analyses using propensity scores were performed to minimize the selection bias in the present observational study. After a median follow-up of 33.5 months, no significant difference was found between the CABG and PCI groups in the risk of death (12.1% vs 14.1%, respectively; p = 0.428) or the risk of a composite of death, myocardial infarction, or cerebrovascular accident (17.5% vs 20.0%, respectively; p = 0.434). The rate of major adverse cardiac and cerebrovascular events was significantly lower in the CABG group than in the PCI group (21.8% vs 35.1%, respectively; p = 0.001); the difference was mainly driven by a decrease in the rate of repeat revascularizations (5.1% vs 22.4%; p <0.001). The analyses after propensity score adjustment and matching corroborated the crude group results. In conclusion, PCI with drug-eluting stents showed a safety profile comparable to that of CABG in patients with unprotected LMCA disease. However, the risk of repeat revascularization was significantly greater in the PCI group.